Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

comparative PRO's of 25 Gy in 5 daily fractions (Ultra hypo fractionation) administered to prostate and 1st centimeter of proximal seminal vesicle, starting mid week and ending mid following week.

PRO's of moderate hypo fractionation, 37,5 Gy in 15 or 36 Gy in 12 daily fractions administered 5 days per week.

Compare experimental ultra hypo fractionation (25 Gy in 5 daily fractions administered starting mid week and ending mid following week) to our standard fractionation (either 37,5 Gy given in 15 daily fractions, or 36 Gy in 12 daily fractions).

* Toxicity analysis will be quantitatively evaluated using CTCAE (v5) at 1, 2 and 5 years post-therapy, and has needed at FU visits. Kaplan-Meier statistical analysis will be used to report toxicity evolution through time.
* median IPSS scores will be reported at 3, 6, 12 months and yearly (1, 2, 3, 4 et 5) post-therapy. IPSS median time to baseline return will be calculated.
* IPSS urinary scores, sexual function (SHIM) and GI toxicity (CTCAE-v5) and quality of life questionnaires ( EPIC-26) will be given at 3, 6 months and yearly thereafter (1, 2, 3, 4 et 5) post-treatment.

grade and compare reported side effects between groups

Andre-Guy Martin

Josee Allard

Andre-Guy Martin, MD,MSc,FRCPC

Josée Allard, MSc

Phase 1-2 study, comparing ultra-hypofractionnated (UH) to a moderately hypofractionnated (MH) radiation therapy, with image guided HDR prostate brachytherapy. Using iso-equivalent doses, a non-inferiority analysis will be done in order to prove UH non-inferior to MH, toxicity wise. Acceptability, tolerability, acute and late toxicity will be reported. MRI visible dominant intra-prostatic lesion will be outlines and variability between radiation oncologists and radiologists will be reported. As secondary objective, biochemical and clinical failure free survival will be reported at 5 \& 10 years.

Phase 1 : consists in a feasibility study (First 28 patients).

Phase 2 : monocentric prospective comparative cohort study.

Recruitment :

* "Centre intégré de cancérologie du CHU de Québec-Université Laval."
* Recruitment period: December 2015 to June 2023

Brachytherapy :

* Implantation under general or spinal anesthesia
* Foley catheter insertion in bladder.
* TRUS prostate localisation.
* Prostate volume measurement.
* Gold fiducial markers (3) insertion.
* Prostate brachytherapy catheters (14 à 21) insertion.
* Cystoscopy for bladder and urethra integrity control.
* Re-insertion of foley catheter after cystoscopy.

Planning imaging: TRUS or CT scan (has needed).

Structures delineation by radiation oncologist (brachytherapist).

* Prostate
* Seminale vesicles
* Rectum
* Colon sigmoïde
* Bladder
* Urethra
* Penile bulb

Dosimetric optimisation

* Oncentra Prostate v. 4.2.2 d'Elekta brachytherapy (Veenendaal, The Netherlands)
* Oncentra Brachy version 4.6 (if under CT scan).

Treatment (brachytherapy dose delivery).

* 15 Gy in one fraction
* Direct interstitial dose monitoring (20 patients or more). Fiber-optic dosimeter inserted in prostate brachytherpy catheter for live dose delivery mesurements.

Foley ablation under full bladder, same day or day after therapy.

Radiotherapy:

* Via IMRT, VMAT or SBRT technics.
* Dose : 25 Gy in 5 fractions administered over a 7 days period. 2 to 3 fractions separated by 2 days, weekend break.
* PTV includes prostate and the first centimeter of seminal vesicle.

Simulation

* one week post brachytherapy
* standard has described in the department procedure manual.
* maximal CT scan slice thickness : 2-3mm.
* uretro-graphy done to identify urogenital sphincter.

Multiparametric MRI

* If no counter-indication and available,
* a T2 tridimensional sequence for prostate delineation
* slice thickness : 1 mm.
* a diffusion weighted sequence will be done.
* a DTI with tractography can be done optionally.
* contrast media (gadolinium) is optional.

Physique

* Linac energy (between 6 MV to 18 MV).
* ARC therapy technique will be used
* planification softwares: Éclipse, Pinnacle or Raystation.
* Portal (kV-kV) imagery will be used for marker match.
* CBCT will be done at each fraction delivered.

Clinical and dosimetric data will be collected prior treatment.

Primary objectives :

* Toxicity analysis will be quantitatively evaluated using CTCAE (v5) at 1, 2 and 5 years post-therapy, and has needed at FU visits. Kaplan-Meier statistical analysis will be used to report toxicity evolution through time.
* median IPSS scores will be reported at 3, 6, 12 months and yearly (1, 2, 3, 4 et 5) post-therapy. IPSS median time to baseline return will be calculated.
* IPSS urinary scores, sexual function (SHIM) and GI toxicity (CTCAE-v5) and quality of life questionnaires ( EPIC-26) will be given at 3, 6 months and yearly thereafter (1, 2, 3, 4 et 5) post-treatment.

Secondary objectives : Biochemical disease-free survival has per Phoenix definition (by American Society of Radiation Oncology - ASTRO) recommendation will be reported using Kaplan-Meier analysis.

Prospective comparative cohort study with non inferiority analysis UH-IMRT combined to 15 Gy HDR Brachytherapy will considerably reduce the treatment fraction delivered while maintaining b-DFS and Side-effects at comparable levels to our actual reported prostate cancer patient population, without lymph nodes involvement (risk being less than 15%). We believe that this therapeutic regime will show to be non-inferior to our actual standard therapeutic regime

Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.

ULTRA-HYPO Fractionated (UHF) Compared to Moderate-HYPO Fractionated (MHF) Prostate IGRT With HDR Brachytherapy BOOST : A Phase 1-2 Study.

quantitatively evaluated using CTCAE (v5) and compare between arms

median IPSS scores will be reported post-therapy and compare between arms at baseline, prior treatment

median IPSS scores will be reported post-therapy and compare between arms at 3 months post-therapy

median IPSS scores will be reported post-therapy and compare between arms at 6 months post-therapy

median IPSS scores will be reported post-therapy and compare between arms at 1 year post-therapy

median IPSS scores will be reported post-therapy and compare between arms at 2 years post-therapy

median IPSS scores will be reported post-therapy and compare between arms at 3 years post-therapy

median IPSS scores will be reported post-therapy and compare between arms at 4 years post-therapy

median IPSS scores will be reported post-therapy and compare between arms at 5 years post-therapy

median EPIC26 scores will be reported post-therapy and compare between arms at baseline, prior treatment

median EPIC26 scores will be reported post-therapy and compare between arms at 3 months post-treatment

median EPIC26 scores will be reported post-therapy and compare between arms at 6 months post-treatment

median EPIC26 scores will be reported post-therapy and compare between arms at 1 year post-treatment

median EPIC26 scores will be reported post-therapy and compare between arms at 2 years post-treatment

median EPIC26 scores will be reported post-therapy and compare between arms at 3 years post-treatment

median EPIC26 scores will be reported post-therapy and compare between arms at 4 years post-treatment

median EPIC26 scores will be reported post-therapy and compare between arms at 5 years post-treatment

median SHIM scores will be reported at baseline prior treatment

median SHIM scores will be reported post-therapy and compare between arms at 3 months post-treatment

median SHIM scores will be reported post-therapy and compare between arms at 6 months post-treatment

median SHIM scores will be reported post-therapy and compare between arms at 1 year post-treatment

median SHIM scores will be reported post-therapy and compare between arms at 2 years post-treatment

median SHIM scores will be reported post-therapy and compare between arms at 3 years post-treatment

median SHIM scores will be reported post-therapy and compare between arms at 4 years post-treatment

median SHIM scores will be reported post-therapy and compare between arms at 5 years post-treatment

Biochemical disease-free survival has per Phoenix definition (by American Society of Radiation Oncology - ASTRO) will be reported using Kaplan-Meier analysis, as well for disease free survival, metastasis free survival and overall survival.

Spots Global Cancer Trial Database for grade and compare reported side effects between groups